A randomized, double-blind, placebo-controlled, 104-week proof-of-concept study to evaluate the efficacy of intravenous prasinezumab in participants with Parkinson's disease carrying a severe mutation in the GBA gene (prevent cognitive decline in GBA-associated PD)

PARKINSON’S DISEASE

PDCCS

Cognitive function measured by MoCA_z., Percentage of participants with diagnosis of PD-MCI defined by MDS Level II criteria., Percentage of participants with diagnosis of PDD., Cognitive function per cognitive domain (at least 2 tests per domain) measured by comprehensive neuropsychological test battery: • Attention and working Memory: TMT A + WAIS IV (LNS) • Executive: Verbal Fluency (animal fluency) + Stroop interference + TMT B • Memory: Hopkins verbal learning test HVLT Delayed Recall + WMS (logical memory) • Visuospatial: Benton’s Judgment of Line Orientation + Hooper Visual Organization Test • Language: Boston naming + WAIS IV (similarities), MDS-UPDRS I-IV (total score and subscores I-IV)., Levodopa-equivalent dosage., Safety outcome measures: ● Safety laboratory tests (hematology, chemistry and coagulation) from baseline over time. ● Incidence of treatment‐emergent abnormal laboratory values and abnormal laboratory values reported as AEs. ● Incidence and severity of AEs. ● Incidence of ADAs. ● ECG assessments from baseline over time; incidence of abnormal ECG assessments., Safety outcome measures: Blood pressure (BP [systolic and diastolic], heart rate, and orthostatic measurement from baseline over time, incidence of abnormal blood pressure [systolic and diastolic], heart rate, and orthostatic changes). ● Incidence of exacerbation of motor and psychiatric side‐effects (including C‐SSRS).

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